Michael Barbella, Managing Editor11.22.23
Nine hundred nineteen days and counting. And the end is still nowhere in sight.
Nowhere in plain sight, anyway. By some estimates, the end could be 2,548 days away, give or take a handful of 24-hour periods.
That final day—sometime in late September 2030—can’t come soon enough for Royal Philips, as it could mark the end of one of the largest and most disruptive product recalls in more than a decade.
Philips has been struggling for 30 months (913 days, give or take a few) to right the wrongs inflicted on sleep apnea sufferers by its faulty CPAP, BiPAP, and mechanical ventilator devices. The Dutch multinational conglomerate initiated the recall on April 26, 2021, upon learning the interior sound abatement foam in its DreamStation product line could possibly break off and enter users’ airways, causing skin, eye, or respiratory tract irritation as well as internal organ damage.
Over the next 17 months, the recall—eventually deemed Class I by the U.S. Food and Drug Administration (FDA)—grew to encompass 5.5 million ventilators, including Philips’ V60 and V60 Plus machines (an oxygen flow safety mechanism problem); the Trilogy Evo ventilator and Evo muffler assembly repair kits (sound abatement foam); the Respironics V60, V60 Plus, and V680 devices (internal electrical circuit issue); CPAP and BiPAP therapy masks with magnetic headgear (potential negative interactions with implantable metal devices); and 386 BiPAP ventilators for possible plastic contamination.
Among the early casualties of Philips’ recall—besides patients—was former CEO Frans van Houten, who spent nearly a dozen years at the helm and orchestrated the firm’s lighting and consumer electronics business divestitures. “If you have three recalls in 10 years, it’s too much. His [van Houten’s] position had become untenable,” InsingerGilissen analyst Jos Versteeg told Reuters last summer, referring to a 2017 defibrillator recall and 2014 medical scanner problems. “This situation is not really under control...”
van Houten’s successor vowed to bring the recall under control, but that pledge soon proved difficult to fulfill. In the first few months of Roy Jakobs’ rule, Philips recalled certain reworked Trilogy 100/200 and Garbin Plus ventilators, as well as some reworked DreamStation devices. In addition, the number of medical device reports filed with the FDA between April 21, 2021, and March 31, 2023, swelled to 105,000, with 385 reported deaths.
Although Philips made considerable progress this past spring in replacing all the machines it pulled from the market—producing 98% of the devices and repair kits in question and shipping surrogate products to 2.83 million affected users—its road to recall redemption remains long and arduous. Besides lingering consent decree negotiations with the U.S. Department of Justice, the company faces an investigation by French bureaucrats, thousands of personal injury/medical monitoring claims, and a massive class-action lawsuit.
Earlier this fall, the company negotiated a $479 million settlement over one set of complaints in the class-action suit, agreeing to pay those who purchased, leased or rented its recalled machines $55-$1,552 per device (depending on the model) and an additional $100 for every machine returned, according to court filings cited by the Washington Post. Philips did not admit any liability, wrongdoing, or fault as part of the settlement.
The payout covers only economic loss claims submitted through the class action; it does not include personal injury and/or wrongful death claims, or medical monitoring requests. Payments—funded through a €575 million kitty set aside for such purposes—could begin next quarter, though the timetable is still subject to change.
Another setback along Philips’ atonement path arrived earlier this fall amid serious accusations about its past knowledge of the faulty breathing machines. An investigation by ProPublica and The Pittsburgh Post-Gazette claimed company executives were aware of the CPAP and BiPAP devices’ disintegrating foam for 11 years before recalling the products.
The media partners based their conclusions by analyzing tens of thousands of reports that showed the company withheld more than 3,700 complaints over 11 years from the FDA and only launched a formal investigation in 2019. “...as the complaints continued to pile up in company files, Philips waged aggressive global marketing campaigns to sell more machines, including new models fitted with the hazardous foam,” the Sept. 27 ProPublica-Post-Gazette article stated. “The devices went to infants, the elderly and at least 700,000 veterans. Philips didn’t stop even after the company learned the foam was breaking down in its ventilators in Japan and had to be replaced—and after tests in the United States revealed the material released chemicals at dangerous levels.
Among them: formaldehyde, a compound used in fertilizer, dyes and glues that has been tied to respiratory problems and certain cancers.”
Philips, naturally, denied the charges. Last December, the company released results from tests on its recalled DreamStation sleep therapy devices that showed exposure to certain emissions is “unlikely to result in appreciable harm to health in patients.”
“Philips had previously responded to ProPublica and the Pittsburgh Post-Gazette in the U.S., and NRC in the Netherlands. The articles do not present new facts and we do not agree with the characterizations made in these articles,” a formal company statement read. “Philips’ priority is patient safety and quality. We understand how important Philips Respironics’ sleep therapy devices and ventilators are to patients that use them. Philips regrets any distress and concern for patients, their families and care providers in this matter, and deeply apologizes for this. Philips acted to protect patient safety by initiating and executing a voluntary recall notification/field safety notice of significant scale.”
Maybe so, but it came too late, patients and former Philips employees contended in the ProPublica-Post Gazette investigation. The article specifically named van Houten and Jakobs as main culprits in the cover-up, contending the former touted “very positive” customer responses to its breathing machines in 2020, and the latter acknowledging (in May 2023) complaints about the devices in 2015. The investigation also noted that Jakobs headed the division responsible for producing sleep apnea machines and ventilators as problems with the foam worsened.
“I truly believe those folks knew about it all along,” a former regulatory supervisor at Philips told ProPublica-Post-Gazette reporters. “They tried to keep it pinned down as much as possible.”
Neither van Houten nor Jakobs commented on the story.
“They knew about it, did nothing about it and then started working on a fix,” Brett Stassi, a kidney cancer patient who is suing Philips, griped to ProPublica-Post-Gazette investigators. “People matter. You only get one chance to do it right.”
Unfortunately, Philips may have already missed that chance.
Read more: bit.ly/3rXMcxa
Check out more of MPO's 2023 year in review:
MDR’s Maddening Merry-Go-Round
A Clean Start for EtO
The Legacy of Elizabeth Holmes
Medtech’s Mega-M&A Is MIA
Nowhere in plain sight, anyway. By some estimates, the end could be 2,548 days away, give or take a handful of 24-hour periods.
That final day—sometime in late September 2030—can’t come soon enough for Royal Philips, as it could mark the end of one of the largest and most disruptive product recalls in more than a decade.
Philips has been struggling for 30 months (913 days, give or take a few) to right the wrongs inflicted on sleep apnea sufferers by its faulty CPAP, BiPAP, and mechanical ventilator devices. The Dutch multinational conglomerate initiated the recall on April 26, 2021, upon learning the interior sound abatement foam in its DreamStation product line could possibly break off and enter users’ airways, causing skin, eye, or respiratory tract irritation as well as internal organ damage.
Over the next 17 months, the recall—eventually deemed Class I by the U.S. Food and Drug Administration (FDA)—grew to encompass 5.5 million ventilators, including Philips’ V60 and V60 Plus machines (an oxygen flow safety mechanism problem); the Trilogy Evo ventilator and Evo muffler assembly repair kits (sound abatement foam); the Respironics V60, V60 Plus, and V680 devices (internal electrical circuit issue); CPAP and BiPAP therapy masks with magnetic headgear (potential negative interactions with implantable metal devices); and 386 BiPAP ventilators for possible plastic contamination.
Among the early casualties of Philips’ recall—besides patients—was former CEO Frans van Houten, who spent nearly a dozen years at the helm and orchestrated the firm’s lighting and consumer electronics business divestitures. “If you have three recalls in 10 years, it’s too much. His [van Houten’s] position had become untenable,” InsingerGilissen analyst Jos Versteeg told Reuters last summer, referring to a 2017 defibrillator recall and 2014 medical scanner problems. “This situation is not really under control...”
van Houten’s successor vowed to bring the recall under control, but that pledge soon proved difficult to fulfill. In the first few months of Roy Jakobs’ rule, Philips recalled certain reworked Trilogy 100/200 and Garbin Plus ventilators, as well as some reworked DreamStation devices. In addition, the number of medical device reports filed with the FDA between April 21, 2021, and March 31, 2023, swelled to 105,000, with 385 reported deaths.
Although Philips made considerable progress this past spring in replacing all the machines it pulled from the market—producing 98% of the devices and repair kits in question and shipping surrogate products to 2.83 million affected users—its road to recall redemption remains long and arduous. Besides lingering consent decree negotiations with the U.S. Department of Justice, the company faces an investigation by French bureaucrats, thousands of personal injury/medical monitoring claims, and a massive class-action lawsuit.
Earlier this fall, the company negotiated a $479 million settlement over one set of complaints in the class-action suit, agreeing to pay those who purchased, leased or rented its recalled machines $55-$1,552 per device (depending on the model) and an additional $100 for every machine returned, according to court filings cited by the Washington Post. Philips did not admit any liability, wrongdoing, or fault as part of the settlement.
The payout covers only economic loss claims submitted through the class action; it does not include personal injury and/or wrongful death claims, or medical monitoring requests. Payments—funded through a €575 million kitty set aside for such purposes—could begin next quarter, though the timetable is still subject to change.
Another setback along Philips’ atonement path arrived earlier this fall amid serious accusations about its past knowledge of the faulty breathing machines. An investigation by ProPublica and The Pittsburgh Post-Gazette claimed company executives were aware of the CPAP and BiPAP devices’ disintegrating foam for 11 years before recalling the products.
The media partners based their conclusions by analyzing tens of thousands of reports that showed the company withheld more than 3,700 complaints over 11 years from the FDA and only launched a formal investigation in 2019. “...as the complaints continued to pile up in company files, Philips waged aggressive global marketing campaigns to sell more machines, including new models fitted with the hazardous foam,” the Sept. 27 ProPublica-Post-Gazette article stated. “The devices went to infants, the elderly and at least 700,000 veterans. Philips didn’t stop even after the company learned the foam was breaking down in its ventilators in Japan and had to be replaced—and after tests in the United States revealed the material released chemicals at dangerous levels.
Among them: formaldehyde, a compound used in fertilizer, dyes and glues that has been tied to respiratory problems and certain cancers.”
Philips, naturally, denied the charges. Last December, the company released results from tests on its recalled DreamStation sleep therapy devices that showed exposure to certain emissions is “unlikely to result in appreciable harm to health in patients.”
“Philips had previously responded to ProPublica and the Pittsburgh Post-Gazette in the U.S., and NRC in the Netherlands. The articles do not present new facts and we do not agree with the characterizations made in these articles,” a formal company statement read. “Philips’ priority is patient safety and quality. We understand how important Philips Respironics’ sleep therapy devices and ventilators are to patients that use them. Philips regrets any distress and concern for patients, their families and care providers in this matter, and deeply apologizes for this. Philips acted to protect patient safety by initiating and executing a voluntary recall notification/field safety notice of significant scale.”
Maybe so, but it came too late, patients and former Philips employees contended in the ProPublica-Post Gazette investigation. The article specifically named van Houten and Jakobs as main culprits in the cover-up, contending the former touted “very positive” customer responses to its breathing machines in 2020, and the latter acknowledging (in May 2023) complaints about the devices in 2015. The investigation also noted that Jakobs headed the division responsible for producing sleep apnea machines and ventilators as problems with the foam worsened.
“I truly believe those folks knew about it all along,” a former regulatory supervisor at Philips told ProPublica-Post-Gazette reporters. “They tried to keep it pinned down as much as possible.”
Neither van Houten nor Jakobs commented on the story.
“They knew about it, did nothing about it and then started working on a fix,” Brett Stassi, a kidney cancer patient who is suing Philips, griped to ProPublica-Post-Gazette investigators. “People matter. You only get one chance to do it right.”
Unfortunately, Philips may have already missed that chance.
Read more: bit.ly/3rXMcxa
Check out more of MPO's 2023 year in review:
MDR’s Maddening Merry-Go-Round
A Clean Start for EtO
The Legacy of Elizabeth Holmes
Medtech’s Mega-M&A Is MIA